Comparative Efficacy of Selective Laser Trabeculoplasty Versus Tafluprost in Primary Treatment of Exfoliation Ocular Hypertension or Glaucoma

The primary objective of this randomized clinical trial is to demonstrate the **equivalence** in efficacy between selective laser trabeculoplasty (SLT) and medical therapy using eye drops as a first-line treatment for exfoliation **glaucoma**. This is clinically relevant as it may provide an alternative treatment option that could potentially reduce the need for long-term medication use, thereby improving patient compliance and quality of life. The study focuses on comparing these two treatment modalities to determine if SLT can be as effective as the current standard medical therapy in managing intraocular pressure in patients with exfoliation ocular hypertension or glaucoma.

The clinical trial focuses on individuals diagnosed with **glaucoma**, specifically exfoliation glaucoma, as per the European Glaucoma Society guidelines. The study population includes both male and female participants, aged between 50 and 100 years. Participants are required to have newly diagnosed exfoliation glaucoma or ocular hypertension with intraocular pressure of 24 mmHg or more, but less than 35 mmHg. The trial does not involve a vulnerable population. Participants must be able to commit to a 12-month study period. The sponsor has not provided information regarding the total number of participants. Lifestyle factors such as diet and physical activity are not specified as part of the trial's considerations.

The clinical trial is designed to evaluate the efficacy of selective laser trabeculoplasty (SLT) compared to **medical therapy** using tafluprost eye drops as a primary treatment for exfoliation **glaucoma**. This is a randomized, controlled, and double-blind trial, ensuring that neither the participants nor the researchers know which treatment the participants are receiving, thus minimizing bias. The trial is categorized as a Phase IV study, indicating it is conducted after the product has been marketed to gather additional information on the drug's effect in various populations and any side effects associated with long-term use.

The trial is expected to last until December 2030, with participant recruitment having commenced in November 2020. Participants will be involved in the study for a maximum treatment period of 120 days. The study includes several key visits: an initial screening visit to confirm eligibility based on criteria such as age (50-100 years), ability to attend the study for 12 months, and a diagnosis of exfoliation glaucoma or ocular hypertension with specific intraocular pressure parameters. Follow-up visits will be scheduled to monitor the primary endpoint, which is the acceleration of treatment by adding eye drops, and secondary endpoints, including eye dryness, eye pressure, and the long-term success of SLT treatment.

The end-of-study visit will assess the cumulative success of SLT treatment and the need for glaucoma surgery. Participants may be withdrawn from the study if they fail to adhere to the protocol, experience adverse effects, or if the study is terminated early for any reason. The trial aims to provide valuable insights into the comparative effectiveness of SLT and tafluprost eye drops, potentially influencing future treatment guidelines for exfoliation glaucoma.

The clinical trial involves the use of **Taflotan®**, an ophthalmic solution formulated as eye drops, containing the active substance **tafluprost**. Taflotan® is presented in single-dose pipettes, with a concentration of 15 micrograms per milliliter. The pharmaceutical form is specifically designed for ophthalmic administration. The maximum daily dose is 0.45 micrograms, and the treatment period is limited to a maximum of 120 days. The active substance, tafluprost, is of chemical origin and is utilized for its therapeutic effects in managing exfoliation ocular hypertension or glaucoma. The administration route is strictly ophthalmic, ensuring direct application to the eye.

In this randomized clinical trial, the experimental medication, Taflotan®, is compared against selective laser trabeculoplasty (SLT) as a first-line treatment. The trial aims to demonstrate the equivalence in efficacy between SLT laser treatment and medical therapy using Taflotan® for patients with exfoliation glaucoma. No additional non-experimental treatments, such as placebo or other comparator treatments, are specified in the trial protocol. Participant compliance with the dosing schedule is monitored to ensure adherence to the prescribed treatment regimen.

Efficacy in this clinical trial will be assessed by comparing the outcomes of selective laser trabeculoplasty (SLT) with medical therapy using **tafluprost** eye drops as a primary treatment for exfoliation glaucoma. The primary endpoint for evaluating efficacy is the acceleration of treatment by the addition of eye drops. Secondary endpoints include the assessment of eye dryness and eye pressure, as well as long-term outcomes such as the cumulative success of SLT treatment and the necessity for glaucoma surgery.